A randomised phase III toxicity study of day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin for patients with International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis germ cell tumours, TE3

ISRCTN	ISRCTN08648791
DOI	https://doi.org/10.1186/ISRCTN08648791
ClinicalTrials.gov number	NCT00324298
Secondary identifying numbers	Version 4.1

Submission date: 20/09/2005
Registration date: 01/12/2005
Last edited: 07/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-for-testicular-cancer

Contact information

Dr Jonathan Shamash
Scientific

Department of Medical Oncology
7th Floor
Gloucester House
St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised phase III toxicity study of day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin for patients with International Germ Cell Cancer Collaborative Group (IGCCCG) good prognosis germ cell tumours, TE3
Study acronym	TE3
Study objectives	This study aims to ascertain whether administering the same total dose of bleomycin by a continuous 72-hour infusion over the first three days of chemotherapy results in lower lung toxicity than if administered conventionally as weekly bolus injections.
Ethics approval(s)	Northern and Yorkshire Multi-Centre REC, 10/07/2003
Health condition(s) or problem(s) studied	IGCCCG Good Prognosis Germ Cell Tumours
Intervention	Day 2, 8, 15 short (30 minute) versus day 1, 2, 3 long (72 hours) infusion bleomycin. In addition to standard care for patients on chemotherapy, which includes biochemical and radiological evaluation of disease, patients will also undergo lung function testing and computed tomography (CT) to assess pulmonary toxicity.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Bleomycin
Primary outcome measure	Pulmonary toxicity, as confirmed by central radiological review of CT scans at 12 weeks after starting treatment
Secondary outcome measures	1. CT scan changes at 6 weeks 2. Quality of life 3. Changes in respiratory function tests 4. Treatment response 5. Progression-free and overall survival
Overall study start date	08/07/2003
Completion date	30/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	212
Key inclusion criteria	1. Patients aged 16 - 50 inclusive 2. Patients with proven good risk metastatic germ cell cancer of the testis 3. Patients eligible for treatment with bleomycin, etoposide and cisplatin 4. Patients who are able to understand their participation in the study and give written consent
Key exclusion criteria	1. Patients who have had previous radiotherapy and/or chemotherapy 2. Patients with creatinine clearance less than 60 ml/min 3. Patients with a previous or concurrent second malignancy, except for basal cell skin cancer 4. Patients with any other major systemic illness 5. Impaired respiratory function i.e. shortness of breath on minimal exertion or hypoxia at rest, transfer coefficient for carbon monoxide (KCO), total lung capacity (TLC), forced expiratory volume in one second (FEV1) less than or equal to 60% predicted
Date of first enrolment	08/07/2003
Date of final enrolment	30/03/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Bartholomew's Hospital

London
EC1A 7BE
United Kingdom

Sponsor information

Barts and The London NHS Trust (UK)
Hospital/treatment centre

Joint R&D Department
Barts & The London NHS Trust
Rutland House
New Road
London
E1 2AX
England
United Kingdom

Phone	+44 207 882 7260
Email	gerry.leonard@bartsandthelondon.nhs.uk
Website	http://www.bartsandthelondon.nhs.uk
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Charity

Orchid Cancer Appeal (UK)

No information available

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/06/2017	07/03/2019	Yes	No

Editorial Notes

07/03/2019: Publication reference added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English).
16/03/2017: No publications found in PubMed, verifying study status with principal investigator.
22/04/2010: This record was updated to coincide with protocol version 4.1 (previous protocol version 3 was registered); all changes can be found in the relevant fields:
1. The overall trial end date was changed from 31/12/2009 to 30/09/2010.
2. The target number of participants was changed from 210 to 212.
15/02/2011: The overall trial end date was changed from 30/09/2010 to 30/03/2011.